Director, Quality Systems and GxP Compliance

Committed to the preservation of vision.
Help bring the first ophthalmic formulation of bevacizumab to people living with wet AMD.Director, Quality Systems and GxP Compliance

Outlook Therapeutics (Nasdaq: OTLK) is a commercial-stage biopharmaceutical company redefining the standard of care in retinal disease. In the United States, our lead product has received FDA approval, making it the first and only FDA-approved ophthalmic formulation of its kind for the treatment of wet AMD, and we are preparing for US commercial launch. Our lead product is also the first ophthalmic formulation of its kind to receive Marketing Authorization from the European Commission and the UK MHRA for the treatment of wet age-related macular degeneration (wet AMD), and has launched across Germany, Austria, and the UK.

Driven by the stories of the patients we serve, we are united with the vision-care community around a single goal: a future where everyone with retinal disease can envision a brighter world.

Reports To – VP, Quality Assurance
Level – Director
Location – Remote (US-based) with global scope
Employment Type – Full-time
Direct Reports – No

This is a rare ground-floor moment at a company hitting its commercial inflection point. As a lean, fast-moving organization, we offer scope and ownership that larger companies can’t: your work is visible, your decisions matter, and you’ll help build the function rather than simply maintain it. You’ll partner directly with senior leadership and see a clear line between what you do and patients gaining access to a new treatment option.

You’ll build and run the quality systems backbone for a company scaling its Quality Management System across the US, EU, UK, MENA, LATAM, and APAC — with direct visibility into inspection readiness as we grow toward global commercial maturity.

Quality Systems & Governance

• Lead Quality Systems and GxP Compliance operations, including Document Control, Change Control, Deviations, CAPA, and Product Complaint support.
• Build and maintain quality programs and the internal Quality Management System.
• Lead the Change Control Review Board and Quality Council.
• Drive continuous improvement across vendor and internal quality systems, incorporating outcomes from Quality Management Review activities.

Vendor & Quality Agreement Management

• Manage external oversight of GxP vendor quality systems.
• Author, maintain, and approve Quality Agreements with GxP vendors.

Audits & Inspection Readiness

• Lead internal and external GxP audit programs.
• Oversee inspection readiness activities, including mock audits and SME preparation.
• Drive timely and effective CAPA completion across the organization.

Investigations, Documentation & Regulatory Compliance

• Review and approve OOS investigations, deviations, and product complaint investigations.
• Write, review, approve, and maintain GxP SOPs and GxP policies.
• Ensure proper execution of required regulatory reporting and drug shortage notifications.
• Lead participation in Annual Product Quality Review activities.
• Ensure Quality System compliance for combination products

Cross-Functional Partnership & Team Enablement

• Provide backup QA support for batch record review and release, and for PPQ and analytical method validation reviews.
• Provide quality and GxP compliance guidance to cross-functional partners across Regulatory, Technical Operations, and Commercial.
• Ensure GxP employees complete required training.
• Represent QA in internal and external meetings.

Required

• Bachelor’s degree in a life-science or related field.
• 10+ years of experience in biopharmaceutical or pharmaceutical Quality.
• Strong knowledge of domestic and international GMP regulations.
• Proven experience building and maintaining Quality Systems.
• Experience partnering with multi-disciplinary teams across Regulatory, Technical Operations, and Commercial.
• Strong organizational and communication skills, with the ability to resolve challenges independently.

Preferred

• Experience with electronic quality systems such as Veeva, Track Wise, or Master Control.
• Experience supporting Quality System compliance for combination products.
• Experience operating in a global,…